Dobby1979
Involved In Discussions
Hi.
This is my first post to Elsmar, have always looked on with great admiration at the replies and assistance people give.
For this reason i was wondering is someone could advise / is a guru on Software Tool Validation, namely compilers!
The FDA guidance on the general principles of software validation implies (to a degree) that they should be validated. In reality this (to me) is a monstrous task with such little value, especially if your V&V is very robust.
Would love to hear your thoughts, experience on this as i am having strong discussions for and against. I am totally for validating tools that have an impact / where the tool output is giving a result but i just cannot get my head around validating a compiler or even how this task would be took on!
Background Info: Class II Medical Device
Thanks in advance and apologies if i have posted in the wrong category.
Dobby
This is my first post to Elsmar, have always looked on with great admiration at the replies and assistance people give.
For this reason i was wondering is someone could advise / is a guru on Software Tool Validation, namely compilers!
The FDA guidance on the general principles of software validation implies (to a degree) that they should be validated. In reality this (to me) is a monstrous task with such little value, especially if your V&V is very robust.
Would love to hear your thoughts, experience on this as i am having strong discussions for and against. I am totally for validating tools that have an impact / where the tool output is giving a result but i just cannot get my head around validating a compiler or even how this task would be took on!
Background Info: Class II Medical Device
Thanks in advance and apologies if i have posted in the wrong category.
Dobby